Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT) - Local adaptation in Germany from global umbrella protocol (CLOU064A2402)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001003
• Study ID:
  1000001003
• Official title and acronym:
  Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT) - Local adaptation in Germany from global umbrella protocol (CLOU064A2402)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a prospective, multi-country, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib.; The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population.; The study employs an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program.; ; This version of the protocol has been tailored to meet the specific requirements of Germany; the local study documentation is a minimized version of the global document set, modified to align with local evidence needs, given local disparities in treatment guidelines, access, legal requirements, physician type and electronic patient-reported outcomes (ePROs)/electronic diaries (eDiaries) used. ; ; The major protocol adaption for Germany from the umbrella protocol is the exclusion of cohort 1: ; • Cohort 1 (Inadequate control of CSU despite licensed dose of sgH1-AH and decision to escalate sgH1-AH treatment.) will not be addressed as this is considered off-label in Germany. ; ; The study has 2 periods: ; • Early frequent observational period (Phase 1): Baseline to week 12 ; • Long-term observational period (Phase 2): From Month 3 to 24 ;
• Study status:
  Planned

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned:24/03/2025

Study start date

Planned:01/06/2026

Data analysis start date

Planned:31/05/2029

Date of interim report, if expected

Planned:30/09/2027

Date of final study report

Planned:31/01/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CLOU064ADE02